- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ongoing process improvement related to data governance to ensure data integrity, quality , consistency, and compliance with regulatory requirements.Define ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key...defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... control and deviation processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is also responsible for… more
- Catalent (St. Petersburg, FL)
- …the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... Compliance ManagerPosition SummarySt. Petersburg is our primary softgel...St. Petersburg site. The Department has the responsibility for Quality aspects including but not limited to Quality… more
- Eisai, Inc (Nutley, NJ)
- …security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory , ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Merck & Co. (Rahway, NJ)
- …result in outcomes that demonstrate the Company's commitment to regulatory compliance . Ensures that a cross-functional team (eg Quality & Continuous ... Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for...and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketed products (drugs and devices). To contribute and support activities related to compliance reporting and quality tasks in order to ensure consistency and ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...of correction, corrective and preventive actions in response to quality and/or compliance issues Collaborate with other… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverable quality , and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Eisai, Inc (Nutley, NJ)
- …Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with ... Safety staff for all marketed and investigational Eisai productsDesigns and conducts quality reviews to verify the accuracy, completeness and validity of information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the trial team according to agreed strategy and plan, optimizing speed, quality and budget in compliance with standard processes, policies and procedures ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with ... amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance . Address recurring ... direction and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... the Quality Unit and could include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused customer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …agreements across a broad spectrum of external entities with a focus on budget, quality , compliance and in alignment with business needs Serve as a subject ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer service. Essential Functions Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and ... Position Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development ... this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies… more
- Tris Pharma (Monmouth Junction, NJ)
- …is Tris Pharma’s Generics division. We are focused on creating high- quality , patient-friendly products that leverage our strengths in product selection, product ... immediate opening in our Monmouth Junction, NJ headquarters for a Case Manager , Specialty PharmacyQualified candidate will have experience providing phone support to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
